Biopharmaceutics and Biologic Drugs

Dixit (graduate from University of Illinois) is a scholastic personality with several patents and publications to his credit and with more than 25 years of rich experience in pharmaceuticals, biopharmaceutical and CRO industries in the area of drug discovery and bio-analytical services. He has extensively worked on method development and validation of various assay platforms such as LC-MS, ELISA, MSD, SPR, RIA/RIPA and Cell based assays for Immunogenicity and pharmacokinetics evaluation of non-clinical and clinical study samples under GLP and GCLP compliant practices for regulatory submission studies. As a test facility management and head of bioanalytical laboratory he has successfully faced multiple sponsor’s and regulatory audits. Dr. Dixit with his expertise is currently guiding the team biologics in the delivery of quality compliant bioanalytical and Characterization services for biologics and biosimilars for submission studies